MAUDE Adverse Event Report: ARTHROCARE CORPORATION 2.8 MM Q-FIX ALL SUTURE ANCHOR; FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD

Catalog Number 25-2800

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem Unspecified Infection (1930)

Event Date 07/25/2014

Event Type  Injury  

Event Description

It was reported that following a shoulder procedure using a 2.8 mm q-fix all suture anchor, the patient returned to the facility two weeks post procedure with an infected implant.The implant was inspected and cleaned by the surgeon.No additional details were provided regarding the outcome, however no further patient complications have been reported.

Manufacturer Narrative

Visual and biological inspection could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.A review of the device history records for the subject lot number shows that the device expiration date is listed as may 2017.A review of the sterility records was performed and all indicate that all eto sterilization tests passed upon release to distribution.Thus, there is no indication that the patient's infection would have been contributed by the device.Because there are no indications to suggest the device did not meet product specifications upon release into distribution, it is possible the infection existed in the patient before the surgical procedure was performed or was induced by another surgical instrument unassociated with the device the ifu contains warnings and precautions for appropriate use of this device.

• Brand Name: 2.8 MM Q-FIX ALL SUTURE ANCHOR
• Type of Device: FIXATION ANCHOR, LIGAMENT, NON-BIODEGRAD
• Manufacturer (Section D): ARTHROCARE CORPORATION; austin TX
• Manufacturer (Section G): ARTHROCARE COSTA RICA; la aurora, heredia ; CS
• Manufacturer Contact: wendy laird ; 7000 w william cannon dr; bldg 1; austin, TX 78735 ; 5123585933
• MDR Report Key: 4199376
• MDR Text Key: 20456205
• Report Number: 3006524618-2014-00311
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Catalogue Number: 25-2800
• Device Lot Number: 1073039
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention